TOLFEDINE CS INJECTION

Ülke: Avustralya

Dil: İngilizce

Kaynak: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktif bileşen:

TOLFENAMIC ACID; BENZYL ALCOHOL

Mevcut itibaren:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Adı):

tolfenamic acid(40mg/mL)

Farmasötik formu:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Kompozisyon:

TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 40.0 mg/ml; BENZYL ALCOHOL BENZENE Other 1.04 %w/v

Paketteki üniteler:

100mL; 250mL; 50mL

Sınıf:

VM - Veterinary Medicine

Terapötik grubu:

CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI

Terapötik alanı:

MUSCULOSKELETAL SYSTEM

Terapötik endikasyonlar:

AGALACTIA | ANTI-INFLAMMATORY AGENT | MASTITIS | METRITIS | PNEUMONIA | ANTIPYRETIC | BACTERIAL PNEUMONIA | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MASTITIS-METRITIS-AGALACTIA | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | SUBCLINICAL MASTITIS | TENDON SPRAINS | TRAUMATIC SWELLING

Ürün özeti:

Poison schedule: 4; Withholding period: MEAT: Cattle by intramuscular administra tion: DO NOT USE less than 10 days befor e slaughter for human consumption. Catt le by intravenous administration: DO NOT USE less than 4 days before slaughter f or human consumption. Pigs by intramusc ular administration: DO NOT USE less tha n 6 days before slaughter for human cons umption. MILK: Cattle by intramuscular or intravenous administration: Milk coll ected from cows within 12 hours (1 milki ng) following treatment MUST NOT BE USED for human consumption or processing. Th is milk should not be fed to bobby calv es. DO NOT USE less than 21 days (pi gs) or 28 days (cattle) before slaughter for export. The ESI on this label was c orrect at the time of label approval. B efore using this product confirm the cur rent ESI from the registrant on 02 9517 1166 or the APVMA website (apvma.gov.au/ residues/ESI.shtml); Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: WHP: MEAT: Cattle by intramuscular adm inistration: DO NOT USE less than 10 da ys before slaughter for human consumpti on. Cattle by intravenous administratio n: DO NOT USE less than 4 days before slaughter for human consumption. Pigs b y intramuscular administration: DO NOT USE less than 6 days before slaughter f or human consumption. MILK: Cattle by i ntramuscular or intravenous administrat ion: Milk collected from cows within 12 hours (1 milking) following treatment MUST NOT BE USED for human consumption or processing. This milk should not be fed to bobby calves. ESI: DO NOT USE l ess than 21 days (pigs) or 28 days (cat tle) before slaughter for export. The E SI on this label was correct at the tim e of label approval. Before using this product confirm the current ESI from t he registrant on 02 9517 1166 or the AP VMA website (apvma. gov.au/residues/ESI .shtml); Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; A non-steroidal anti-inflammatory analgesic - antipyretic for use in cattle and pigs.See RESTRAINTS & PRECAUTIONS on label.

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2023-07-01

Bilgilendirme broşürü

Product Name:
APVMA Approval No:
TOLFEDINE CS INJECTION
52850/129251
Label Name:
TOLFEDINE CS INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
40 mg/mL TOLFENAMIC ACID
1.04 %w/v BENZYL ALCOHOL as a preservative
Claims:
A non-steroidal anti-inflammatory anlagesic-antipyretic for use in
cattle and pigs.
For use by or under the direction of a registered veterinarian.
As an aid in the treatment of pneumonia and acute mastitis in cattle
and metritis-mastitis-
agalactia in pigs.
Net Contents:
50mL
100mL
250mL
Directions for Use:
Restraints:
DO NOT inject cattle other than into muscle tissue high on the side of
the neck. Injection
of product into muscles other than as described is likely to result in
residues in meat and
above the MRL or ESI.
Re-treatment intervals: A single treatment regime consists of either 1
x intravenous
injection (cattle) or 2 x intramuscular injections at 48 h (cattle) or
1 x intramuscular injection
(pigs). DO NOT repeat treatment less than 21 days after treatment of
pigs, or 28 days after
last treatment of cattle.
Contraindications:
Precautions:
Safe use of TOLFEDINE CS Injection during pregnancy has not been
established. RLP APPROVED
Side Effects:
Dosage and
Administration:
Discard unused portion within 28 days after first broaching the vial.
Cattle: Pneumonia: 2 mg/kg (1 mL/20 kg bw) by intramuscular injection
high in the neck.
Treatment may be repeated once after 48 hours.
Mastitis: 4 mg/kg (1 mL/10 kg bw) as a single intravenous injection.
Pigs: Metritis-mastitis-agalactia: 2 mg/kg (1 mL/20 kg bw) as a single
intramuscular
injection into the rump.
General Directions:
PHARMACOLOGY
Pharmacodynamic properties
Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) is a
non-steroidal anti-
inflammatory drug (NSAID) belonging to the fenamate group. Tolfenamic
acid exerts
anti-inflammatory, analgesic and antipyretic activities. The
anti-inflammatory activity of
tolfenamic acid is mainly due to an inhibition

Ürün özellikleri

PRODUCT NAME: TOLFEDINE CS INJECTION
PAGE: 1 OF 5
THIS VERSION ISSUED: JANUARY, 2016
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: [phone]
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: [phone] (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: [phone]
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Tolfedine is a highly effective and safe Non Steroidal
Anti-Inflammatory, COX-2
preferential inhibitor.
TRADE NAME:
TOLFEDINE CS INJECTION
APVMA CODE:
52850
PRODUCT USE:
Nonsteroidal anti-inflammatory, analgesic, antipyretic for cattle and
pigs.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
JANUARY, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xi, Irritating. N, Dangerous to the environment. Hazardous according
to the criteria of
SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P402+P404: Store in a dry place. Store in a closed container.
P403+P235: Store in a well-ventilated place. Keep cool, below 30°C.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with

Güvenlik Bilgi Formu

PRESCRIPTION
ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_T_
_OLFEDINE_
_®_
_CS_
_INJECTION_
TOLFENAMIC ACID 40MG/ML
CONTAINS 1.04% W/V BENZYL ALCOHOL
AS A PRESERVATIVE.
A NON-STEROIDAL ANTI-INFLAMMATORY
ANALGESIC-ANTIPYRETIC FOR USE IN
CATTLE AND PIGS.
100ML
READ THE ENCLOSED LEAFLET BEFORE
USING THIS PRODUCT
INDICATIONS
FOR USE BY OR UNDER THE DIRECTION OF A REGISTERED
VETERINARIAN AS AN AID IN THE TREATMENT OF
PNEUMONIA AND ACUTE MASTITIS IN CATTLE AND
METRITIS-MASTITIS-AGALACTIA IN PIGS.
DIRECTIONS FOR USE
RESTRAINTS: DO NOT INJECT CATTLE OTHER THAN INTO
MUSCLE
TISSUE
HIGH
ON
THE
SIDE
OF
THE
NECK
(SEE LEAFLET FOR DIAGRAM). INJECTION OF PRODUCT INTO
MUSCLES OTHER IN RESIDUES IN MEAT ABOVE THE MRL
OR ESI.
PRECAUTIONS:
Repeat treatments or higher doses
could result in residues above the MRL unless the label
withholding period is extended. The prescribing
Veterinarian would need to advise on an extended
withholding
period.
Safe
use
of
TOLFEDINE
CS
Injection during pregnancy has not been established.
DOSAGE AND ADMINISTRATION:
USE THE CONTENTS WITHIN 3 MONTHS OF FIRST
BROACHING OF THE VIAL. DISCARD THE UNUSED
PORTION.
RE-TREATMENT INTERVAL: A single treatment regime
consists of either 1 x IV injection (cattle) or 2 x IM
injections at 48h (cattle) or 1 x IM injection (pigs). DO
NOT repeat treatment less than 21 days after treatment
of pigs, or 28 days after last treatment of cattle.
CATTLE – PNEUMONIA: 2mg/kg (1mL per 20kg bw)
by intramuscular injection high in the neck (see leaflet
for diagram). Treatment may be repeated once only
after 48 hours.
Mastitis: 4mg/kg (1mL per 10kg bw) as a single
intravenous injection.
PIGS – METRITIS-MASTITIS-AGALACTIA: 2mg/kg
(1mL per 20kg bw) as a single intramuscular injection.
WITHHOLDING PERIODS
MEAT
CATTLE BY INTRAMUSCULAR ADMINISTRATION: DO NOT
USE LESS THAN 10 DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
CATTLE BY INTRAVENOUS ADMINISTRATION: DO NOT
USE LESS THAN 4 DAYS BEFORE SLAUGHTER FOR
HUMAN CONSUMPTION.
PIGS BY INTRAMUSCULAR ADMINISTRATION: